La MDCG publica este recordatorio para pedir paciencia a los que pedimos una MEDDEV 2.7/1 rev4 para MDR e IVDR, quiere pues complementar la MDCG 2020-6
Lo reproducimos aqui …
Appendix I – Sections of MEDDEV 2.7/1 rev. 4 which are still relevant under the MDR for the application of this guidance
The identified sections of MEDDEV 2.7/1 rev. 4 are considered relevant to MDR as they contain helpful information regarding how to perform activities associated with clinical evaluation:
– 6.4. Who should perform the clinical evaluation?
– 8. Identification of pertinent data (Stage 1)
– 9. Appraisal of pertinent data (Stage 2)
– 10. Analysis of the clinical data (Stage 3). This chapter includes references to the MDD, MDR requirements should be used instead
– A3. Device description – typical contents
– A4. Sources of literature
– A5. Literature search and literature review protocol, key elements
– A6. Appraisal of clinical data – examples of studies that lack scientific validity for demonstration of adequate clinical performance and/or clinical safety
– A7.2. Conformity assessment with requirement on acceptable benefit/risk profile
– A7.3. Conformity assessment with requirement on performance
– A7.4. Conformity assessment with requirements on acceptability of undesirable side-effects
– A10. Proposed checklist for the release of the clinical evaluation report.